FDA.reportPublic FDA data

Drug Mart Polyethylene Glycol 3350 Drug fact

Manufacturer
DISCOUNT DRUG MART
Effective date
2026-09-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-09-15 03:02:27

Label at a glance#

ProductDiscount Drug Mart
Active ingredientPOLYETHYLENE GLYCOL 3350
Label structure11 sections

Dosage and administration

• do not take more than directed unless advised by your doctor • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap) • adults and children 17 years of age and older: o use once a day o fill to top of white section in cap which is marked to indicate the correct dose (17 g) o stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or r...

Storage and handling

• store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each dose)

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 3350, 17 g (cap filled to line)

Purpose

OTC - PURPOSE SECTION

Osmotic Laxative

Use

INDICATIONS & USAGE SECTION

  • relieves occasional constipation /irregularity
  • generally produces a bowel movement in 1 to 3 days

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

Do not use if you are allergic to polyethylene glycol

OTC - DO NOT USE SECTION

Do not use if you have kidney disease, except under the advice and supervision of a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • nausea, vomiting or abdominal pain
  • a sudden change in bowel habits that lasts over 2 weeks
  • irritable bowel syndrome

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor of pharmacist before use if you are taking a prescription drug

OTC - WHEN USING SECTION

When using this product you may have loose, watery, more frequent stools

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or your nausea, bloating or cramping or abdominal pain gets worse. These may be signs of a serious condition.
  • you get diarrhea
  • you need to use a laxative for longer than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed unless advised by your doctor
  • the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line (white section in cap)
  • adults and children 17 years of age and older:
    • use once a day
    • fill to top of white section in cap which is marked to indicate the correct dose (17 g)
    • stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
    • do not combine with starch-based thickeners used for difficulty swallowing
    • ensure that the powder is fully dissolved before drinking
    • do not drink if there are any clumps
    • do not use no more than 7 days
  • children 16 years of age or under: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

none

Questions or comments?

OTC - QUESTIONS SECTION

1-866-467-2748

TAMPER-EVIDENT: DO NOT USE IF FOIL SEAL UNDER CAP, PRINTED WITH "SEALED FOR YOUR PROTECTION" IS MISSING, OPEN OR BROKEN

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISCOUNT DRUG MART

NDC 53943-652-14

Polyethylene Glycol 3350,

Powder for Solution,

Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

UNFLAVORED POWDER
14 ONCE-DAILY DOSES

NET WT 8.3 OZ (238 g)

  • Dissolves in ANY Beverage

DISTRIBUTED BY: DRUG MART-FOOD FAIR

MEDINA, OHIO 44256

www.DISCOUNT-DRUGMART.COM

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATIFACTION, NAME, ADRESS AND PACKAGE TO:

DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 044256

*This product is not manufactured or distributed by Bayer HealthCare LLC, the distributor of MiraLAX®

DDM Polyethylene Glycol3350 14 Once Daily Doses
DDM Polyethylene Glycol3350 14 Once Daily Doses

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISCOUNT DRUG MART

NDC 53943-652-30

Polyethylene Glycol 3350,

Powder for Solution,

Osmotic Laxative

  • Relieves Occasional Constipation/Irregularity
  • Softens Stool

UNFLAVORED POWDER
30 ONCE-DAILY DOSES

NET WT 17.9 OZ (510g)

DDM Polyethylene Glycol3350 30Once Daily Dose
DDM Polyethylene Glycol3350 30Once Daily Dose

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53943-652-142025-03-26C16284748780-12cef2736-97c6-d83d-e063-dadaa90ab31fDrug Mart Polyethylene Glycol 3350 Drug fact
53943-652-142025-03-26C16284748780-12cef2736-97c6-d83d-e063-dadaa90ab31fDrug Mart Polyethylene Glycol 3350 Drug fact
53943-652-302025-03-26C16284748780-12cef2736-97c6-d83d-e063-dadaa90ab31fDrug Mart Polyethylene Glycol 3350 Drug fact
53943-652-302025-03-26C16284748780-12cef2736-97c6-d83d-e063-dadaa90ab31fDrug Mart Polyethylene Glycol 3350 Drug fact
53943-652-142025-01-30C16284748780-12cef2736-97c6-d83d-e063-dadaa90ab31fDrug Mart Polyethylene Glycol 3350 Drug fact
53943-652-142025-01-30C16284748780-12cef2736-97c6-d83d-e063-dadaa90ab31fDrug Mart Polyethylene Glycol 3350 Drug fact
53943-652-302025-01-30C16284748780-12cef2736-97c6-d83d-e063-dadaa90ab31fDrug Mart Polyethylene Glycol 3350 Drug fact
53943-652-302025-01-30C16284748780-12cef2736-97c6-d83d-e063-dadaa90ab31fDrug Mart Polyethylene Glycol 3350 Drug fact

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53943-65253943-652-30, 53943-652-14

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 3350G2M7P15E5PACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-03-24full-release2026-06-01 00:57:50

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202071-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-2884e616aacf4f…
2026-08-18 06:07:402026-07A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-283f01610625f2…
2019-09-15 20:21 UTC2019-09A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202071-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2012-12-28f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4386f353-194b-41d8-8c47-488c0df3b84f9dc3679f-22b3-4f0c-ba06-9ffa875799e72025-03-24WarningsExact identifier
spl set id: 9dc3679f-22b3-4f0c-ba06-9ffa875799e7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.